Dr. Scott Levenson has participated in clinical research trials since 1991 in more than 100 studies at University of California San Francisco, Kaiser San Francisco, and in Redwood City, CA. These studies have involved the following conditions: heartburn, erosive esophagitis, peptic ulcer disease, H. Pylori, dyspepsia, Crohns disease, ulcerative colitis, irritable bowel syndrome, diarrhea, C. difficile, gastric cancer, colon cancer, and others.

A clinical research trial is used in medicine to evaluate new drugs, medical devices, biologics, or other interventions on patients in strictly scientifically controlled settings, and are required for regulatory authority approval of new therapies. Trials may be designed to assess the safety and efficacy of an experimental therapy, to assess whether the new intervention is better than standard therapy, or to compare the efficacy of two standard or marketed interventions. The trial objectives and design are usually documented in a clinical trial protocol. A placebo, an inert compound, identical in appearance to a medication being studied, is sometimes used in clinical research trials.

Good clinical practice guidelines are standards provided by International Conference on Harmonisation (ICH) - an international body that regulates clinical trials involving human subjects. These guidelines include protection of human rights as a subject in clinical trial, how clinical trials should be conducted, define the roles and responsibilities of clinical trial sponsors, clinical research investigators, and Clinical research associates.

An institutional review board/independent ethics committee (IRB/IEC) (also known as ethical review board) is a group that has been formally designated to review and monitor biomedical and behavioral research involving human subjects. In the United States, IRBs are mandated by the Research Act of 1974, which defines IRBs and requires them for all research that receives funding, directly or indirectly, from the Department of Health and Human Services (HHS). In accordance with Food and Drug Administration (FDA) and HHS regulations, an IRB has the authority to approve, require modifications in (to secure approval), or disapprove research. An IRB performs critical oversight functions for research conducted on human subjects that are scientific, ethical, and regulatory.

The following clinical research trials are ongoing at Dr. Levenson’s and Dr. Kao’s office:

Irritable Bowel Syndrome - A 12 week trial of a opioid receptor agonist (medication that helps reduce abdominal pain/discomfort) in patients with moderate to severe diarrhea and abdominal pain.

Irritable Bowel Syndrome (Lotronex study) - A 12 week trial to evaluate Lotronex (a Food and Drug Administration approved medication) in patients with moderate to severe diarrhea and abdominal pain.

Ulcerative Colitis - A 6 week study to evaluate the efficacy and safety of budesonide foam (a localized steroid medication) in patients with ulcerative colitis (an inflammatory disease of the colon). All patients who complete this study will be eligible to enroll in a long-term maintenance study with this medication.

Crohn's Disease - An 8 week study evaluating the efficacy of a medication in patients with moderate to severe Crohn's Disease (an inflammatory disease of the colon) who have failed or are intolerant to anti-TNF medications (i.e. Humira, Cimzia, Remicade) therapy. All patients who complete this study will be eligible to enroll in a long term maintenance study with this medication.

If you are interested in any of the above mentioned studies or for more information, please call (650) 596-8800, extension 19.

Please continue to check this website for additional study details as they begin! Thank you.